Agency classClass IIOur severity:High FDA (Devices)·Z-0848-2019·Announced 2019-02-27

Ortho-Clinical Diagnostics Recalls VITROS VALP Reagent Packs Due to Negative Bias

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VALP Reagent Packs because they may produce negative bias results when measuring valproic acid.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of harm (negative bias in diagnostic results) where specific injury or illness has not been reported in the source text.

Plain-English summary

Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products VALP Reagent Packs, catalog number 6801710. These in vitro diagnostic products are used on VITROS 5,1 FS, 4600, and 5600 Chemistry Systems to measure valproic acid concentration in human serum and plasma.

The recall was initiated because the reagent may produce negative bias results. The affected lots are 25-5263, 25-5503, 25-5727, 25-5974, 25-6067, and 25-6393. A total of 9,014 units were distributed worldwide, with 6,798 units in the United States and 2,216 units in other countries including Australia, Canada, and the United Kingdom.

Healthcare facilities and laboratories should stop using the affected reagent packs and contact Ortho-Clinical Diagnostics for instructions on return or replacement. This recall is classified as Class II by the FDA.

The recalled product

Product: VITROS Chemistry Products VALP Reagent Pack. For in vitro diagnostic use only. CATALOG #(s): 6801710 INTENDED USE: For in vitro diagnostic use only. VITROS Chemistry Products VALP Reagent is used on the VITROS 5,1 FS Chemistry System, the VITROS 4600 Chemistry System and…
Manufacturer: Ortho-Clinical Diagnostics
Category: Medical Device — In Vitro Diagnostic Reagent
Hazard: mis-labeling
diagnostic-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

Affected Lots/Expiry: 25-5263 2017-09-09
25-5503 2018-01-06
25-5727 2018-04-30
25-5974 2018-08-14
25-6067 2018-11-05
25-6393 2019-04-05 (only non expired lot) Unique Identifier:10758750006748

Distribution

Distributed nationwide across the United States.

Same manufacturer · Ortho-Clinical Diagnostics

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Same hazard · mis labeling